Long-Term Safety of In Utero Exposure to Anti-TNFα Drugs for the Treatment of Inflammatory Bowel Disease: Results from the Multicenter European TEDDY Study. Chaparro, M., Verreth, A., Lobaton, T., Gravito-Soares, E., Julsgaard, M., Savarino, E., Magro, F., Avni Biron, I., Lopez-Serrano, P., Casanova, M. J., Gompertz, M., Vitor, S., Arroyo, M., Pugliese, D., Zabana, Y., Vicente, R., Aguas, M., Bar-Gil Shitrit, A., Gutierrez, A., Doherty, G. A., Fernandez-Salazar, L., Martínez Cadilla, J., Huguet, J. M., O'Toole, A., Stasi, E., Manceñido Marcos, N., Villoria, A., Karmiris, K., Rahier, J. F., Rodriguez, C., Diz-Lois Palomares, M., Fiorino, G., Benitez, J. M., Principi, M., Naftali, T., Taxonera, C., Mantzaris, G., Sebkova, L., Iade, B., Lissner, D., Ferrer Bradley, I., Lopez-San Roman, A., Marin-Jimenez, I., Merino, O., Sierra, M., Van Domselaar, M., Caprioli, F., Guerra, I., Peixe, P., Piqueras, M., Rodriguez-Lago, I., Ber, Y., van Hoeve, K., Torres, P., Gravito-Soares, M., Rudbeck-Resdal, D., Bartolo, O., Peixoto, A., Martin, G., Armuzzi, A., Garre, A., Donday, M. G., Martín de Carpi, F. J., & Gisbert, J. P. American Journal of Gastroenterology, 113(3):396–403, 2018.
doi  abstract   bibtex   
OBJECTIVES: The long-term safety of exposure to anti-tumor necrosis factor (anti-TNFα) drugs during pregnancy has received little attention. We aimed to compare the relative risk of severe infections in children of mothers with inflammatory bowel disease (IBD) who were exposed to anti-TNFα drugs in utero with that of children who were not exposed to the drugs. METHODS: Retrospective multicenter cohort study. Exposed cohort: children from mothers with IBD receiving anti-TNFα medication (with or without thiopurines) at any time during pregnancy or during the 3 months before conception. Non-exposed cohort: children from mothers with IBD not treated with anti-TNFα agents or thiopurines at any time during pregnancy or the 3 months before conception. The cumulative incidence of severe infections after birth was estimated using Kaplan-Meier curves, which were compared using the log-rank test. Cox-regression analysis was performed to identify potential predictive factors for severe infections in the offspring. RESULTS: The study population comprised 841 children, of whom 388 (46%) had been exposed to anti-TNFα agents. Median follow-up after delivery was 47 months in the exposed group and 68 months in the non-exposed group. Both univariate and multivariate analysis showed the incidence rate of severe infections to be similar in non-exposed and exposed children (1.6% vs. 2.8% per person-year, hazard ratio 1.2 (95% confidence interval 0.8-1.8)). In the multivariate analysis, preterm delivery was the only variable associated with a higher risk of severe infection (2.5% (1.5-4.3)). CONCLUSIONS: In utero exposure to anti-TNFα drugs does not seem to be associated with increased short-term or long-term risk of severe infections in children.Am J Gastroenterol advance online publication, 20 February 2018; doi:10.1038/ajg.2017.501.
@article{chaparro_long-term_2018,
	title = {Long-{Term} {Safety} of {In} {Utero} {Exposure} to {Anti}-{TNFα} {Drugs} for the {Treatment} of {Inflammatory} {Bowel} {Disease}: {Results} from the {Multicenter} {European} {TEDDY} {Study}},
	volume = {113},
	issn = {1572-0241},
	shorttitle = {Long-{Term} {Safety} of {In} {Utero} {Exposure} to {Anti}-{TNFα} {Drugs} for the {Treatment} of {Inflammatory} {Bowel} {Disease}},
	doi = {10.1038/ajg.2017.501},
	abstract = {OBJECTIVES: The long-term safety of exposure to anti-tumor necrosis factor (anti-TNFα) drugs during pregnancy has received little attention. We aimed to compare the relative risk of severe infections in children of mothers with inflammatory bowel disease (IBD) who were exposed to anti-TNFα drugs in utero with that of children who were not exposed to the drugs.
METHODS: Retrospective multicenter cohort study. Exposed cohort: children from mothers with IBD receiving anti-TNFα medication (with or without thiopurines) at any time during pregnancy or during the 3 months before conception. Non-exposed cohort: children from mothers with IBD not treated with anti-TNFα agents or thiopurines at any time during pregnancy or the 3 months before conception. The cumulative incidence of severe infections after birth was estimated using Kaplan-Meier curves, which were compared using the log-rank test. Cox-regression analysis was performed to identify potential predictive factors for severe infections in the offspring.
RESULTS: The study population comprised 841 children, of whom 388 (46\%) had been exposed to anti-TNFα agents. Median follow-up after delivery was 47 months in the exposed group and 68 months in the non-exposed group. Both univariate and multivariate analysis showed the incidence rate of severe infections to be similar in non-exposed and exposed children (1.6\% vs. 2.8\% per person-year, hazard ratio 1.2 (95\% confidence interval 0.8-1.8)). In the multivariate analysis, preterm delivery was the only variable associated with a higher risk of severe infection (2.5\% (1.5-4.3)).
CONCLUSIONS: In utero exposure to anti-TNFα drugs does not seem to be associated with increased short-term or long-term risk of severe infections in children.Am J Gastroenterol advance online publication, 20 February 2018; doi:10.1038/ajg.2017.501.},
	language = {eng},
	number = {3},
	journal = {American Journal of Gastroenterology},
	author = {Chaparro, M. and Verreth, A. and Lobaton, T. and Gravito-Soares, E. and Julsgaard, M. and Savarino, E. and Magro, F. and Avni Biron, I. and Lopez-Serrano, P. and Casanova, M. J. and Gompertz, M. and Vitor, S. and Arroyo, M. and Pugliese, D. and Zabana, Y. and Vicente, R. and Aguas, M. and Bar-Gil Shitrit, A. and Gutierrez, A. and Doherty, G. A. and Fernandez-Salazar, L. and Martínez Cadilla, J. and Huguet, J. M. and O'Toole, A. and Stasi, E. and Manceñido Marcos, N. and Villoria, A. and Karmiris, K. and Rahier, J. F. and Rodriguez, C. and Diz-Lois Palomares, M. and Fiorino, G. and Benitez, J. M. and Principi, M. and Naftali, T. and Taxonera, C. and Mantzaris, G. and Sebkova, L. and Iade, B. and Lissner, D. and Ferrer Bradley, I. and Lopez-San Roman, A. and Marin-Jimenez, I. and Merino, O. and Sierra, M. and Van Domselaar, M. and Caprioli, F. and Guerra, I. and Peixe, P. and Piqueras, M. and Rodriguez-Lago, I. and Ber, Y. and van Hoeve, K. and Torres, P. and Gravito-Soares, M. and Rudbeck-Resdal, D. and Bartolo, O. and Peixoto, A. and Martin, G. and Armuzzi, A. and Garre, A. and Donday, M. G. and Martín de Carpi, F. J. and Gisbert, J. P.},
	year = {2018},
	pmid = {29460920},
	keywords = {Article, Digestiu},
	pages = {396--403},
}
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